Clinical Trial

Evaluating Laser Otoscope for Middle Ear Effusion Detection

Not Yet Recruiting
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Record status
This record was last updated March 6, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are: -Accuracy and usability of doctors using laser otoscopes Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
Trial Details
NCT Number NCT07454512
Lead Sponsor MSTATT LLC
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), The Cleveland Clinic
Conditions Middle Ear Effusion, Otitis Media
Enrollment 150 participants
Start Date 2026-03-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-06